Product News and Recalls

FDA Warns of Infections from Reprocessed Flexible Bronchoscopes

infection risks elevated on reprocessed bronchoscopesThe U.S. Food and Drug Administration (FDA) recently issued a safety communication about infections associated with the use of reprocessed flexible bronchoscopes. The notice comes as part of the agency’s ongoing investigation into infections caused by reprocessed reusable medical devices, such as duodenoscopes.

A flexible bronchoscope is a long, thin fiber-optic tube that is inserted into a patient’s throat through the mouth or nose. It allows the physician to visually examine their patient’s airways for obstructions and abnormalities. The FDA estimates that 500,000 bronchoscopy procedures are performed each year in the United States.

Once a reusable flexible bronchoscope has been employed in an operation, it is then “reprocessed” for future use. Reprocessing is a detailed procedure that involves thoroughly disinfecting or sterilizing the device. If cleaning instructions are not strictly adhered to, there is a chance the reprocessed device may remain contaminated, and thus expose future patients to risk of infection.

The FDA examined medical device reports submitted by health care facilities and device manufacturers and identified 109 reports from January 2010 to June 2015 concerning infections or device contamination related to reprocessed flexible bronchoscopes. While not necessarily an alarming five-year figure, nearly half of these reports were submitted in 2014. According to the FDA, a small number of these reports indicated “persistent device contamination despite following the manufacturer’s reprocessing instructions.”

The FDA has identified two recurrent themes in reports of device contamination. The first is failure to meticulously follow manufacturer instructions for reprocessing; the second is continued reuse of devices despite issues with integrity, maintenance, or mechanical failure. The agency has recommended that facilities and personnel who reprocess flexible bronchoscopes strictly follow manufacturers’ reprocessing instructions, remove from circulation or replace any bronchoscope that fails a leak test, adhere to guidelines for preventative maintenance and repair, implement a comprehensive reprocessing quality control program, safely store bronchoscopes after reprocessing, and consult appropriate literature regarding bronchoscope reprocessing.

Patients are advised to discuss the risks and benefits of bronchoscopy procedures with their doctor, as well as ask what to expect after the procedure and when to seek medical attention.

Consumers and patients should be able to rely on the safety of medical devices and those responsible for maintaining them. If you believe you or someone you know contracted an infection from a contaminated flexible bronchoscope or other medical device, contact the medical device attorneys at Lopez McHugh. Through a free consultation we can help you determine whether a product liability or medical malpractice lawsuit is right for you.